Fluorouracil
- Product NDC
- 0378-4791
- 11-digit product format
- 003784791
- Labeler code
- 0378
- Product ID
- 0378-4791_1ff72539-1af5-41bf-8720-1ba12df35abc
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Fluorouracil
- Dosage form
- CREAM
- Route
- TOPICAL
- Labeler
- Mylan Pharmaceuticals Inc.
- Application
- NDA016831
- Marketing category
- NDA AUTHORIZED GENERIC
- Marketing start
- 2013-09-19
- Substance
- FLUOROURACIL
- Active strength
- 5 mg/g
- Pharmacologic classes
- Nucleic Acid Synthesis Inhibitors [MoA], Nucleoside Metabolic Inhibitor [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Fluorouracil
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| FLUOROURACIL | 5 mg/g |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | U3P01618RT |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 0378-4791-06 | Fluorouracil | 1 in 1 CARTON | CREAM | 1 | | 11 |
| 0378-4791-06 | Fluorouracil | 40 g in 1 TUBE | CREAM | 40 | | 11 |
DailyMed Socrata Ingredients#
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0378-4791 | FLUOROURACIL CREAM [MYLAN PHARMACEUTICALS INC.] | 11 | Current NDC, Legacy NDC, 2 package rows | 20230708_744737c5-0d96-4214-82ab-6cff016b1ea0.zip |
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 0378-4791-06 | 00378479106 | 1 TUBE in 1 CARTON (0378-4791-06) / 40 g in 1 TUBE | 1 tube | 2013-09-19 | 0000-00-00 | No | No | Current |